Neonatal Skin Care Study

Purpose
Poor skin integrity may be a factor in the increased risk for nosocomial infection noted in ELBW infants. The purpose of this study was to evaluate the effect of prophylactic application of Aquaphor Original® emollient ointment during the first two weeks of life on the incidence of mortality and/or nosocomial bacterial sepsis at 28 days of age in infants of birth weight 501 to 1000 grams compared to those infants receiving routine skin care.

Study Design
Randomized controlled multicenter trial at 53 centers of the Vermont Oxford Network

Methods
Infants of birth weight 501-1000 gm and gestational age less than or equal to 30 wks who were expected to survive more than 48 hrs were stratified into two weight groups (501-750 gm, 751-1000 gm) and randomly assigned to receive generalized application of Aquaphor over the entire body twice a day through day 14 [Prophylactic group (P)] or PRN local application of Aquaphor to site of injury [Routine Skin Care (R)].

Results
Study groups (P=602, R=589) were comparable except that more infants in the prophylactic group received prenatal care (96.8% vs. 94.4%, p=0.04) and were male (54.3% vs. 47.3%, p=0.02). No difference was found in the combined primary outcome of NBS or death [33.6% P vs. 30.3% R, Relative Risk (RR) 1.10, 95% CI 0.94,1.31]. The incidence of death was no different between the groups (10.8% P vs. 12.1% R, RR 0.89; 95% CI 0.65,1.23). More infants in the prophylactic group had NBS (25.8% P vs. 20.4% R, RR 1.26; 95% CI 1.02,1.56), with the increase exclusively due to coagulase negative staphylococcus (CNS)(18.6% P vs. 13.3% R, RR 1.40; 95% CI 1.08,1.83). In the subgroup analysis, the increase in NBS was found only in infants 501-750 gms (28.9% P vs. 20.9% R, RR 1.60; 95% CI 1.07,2.39). Infants in the prophylactic group had better skin condition on days 1-14 of life and less skin injury days 15-28 of life. There was no difference between groups in the outcomes of fungal sepsis, or other complications of prematurity.

Conclusions
Prophylactic application of Aquaphor ointment did not lead to a difference in death and/or NBS in the first 28 days of life. NBS was more frequent in the prophylactic group, with the difference predominantly in the lower weight stratum (501-750 gm) and when CNS was the causal organism.

Publication
Edwards WH, Conner JM, Soll RF; Vermont Oxford Network Neonatal Skin Care Study Group. The effect of prophylactic ointment therapy on nosocomial sepsis rates and skin integrity in infants with birth weights of 501 to 1000 g. Pediatrics. 2004;113: 1195-1203. PubMed: 15121929

Sponsor
Beiersdorf Inc.